What are the responsibilities and job description for the Instrument Software Validation Analyst position at VDart, Inc.?
Title: Instrument Software Validation Analyst
Location: Cincinnati, OH (Onsite)
Type: Contract
Overview
We are seeking an experienced Instrument Software Validation Analyst to ensure that laboratory, manufacturing, and embedded software systems operate reliably, compliantly, and in accordance with regulatory requirements (GxP/FDA/EMA). The role focuses on maintaining validated systems through structured validation processes (IQ/OQ/PQ) and serves as a bridge between technical software testing and regulatory compliance.
Key Responsibilities
Software Validation & Compliance
- Validate software installed on laboratory and manufacturing instruments in compliance with EMA, FDA, and GxP guidelines
- Develop and execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Ensure systems remain in a validated state throughout their lifecycle
Documentation & Regulatory Support
- Author and maintain validation documentation including:
- Validation Plans and Reports
- User Requirement Specifications (URS)
- Functional/Design Specifications
- Traceability Matrices
- Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards
System Analysis & Design
- Gather and document system requirements
- Develop software specifications and validation test cases
- Create infrastructure diagrams and data flow documentation
- Document current-state software configurations
Testing & Execution
- Perform functional, integration, regression, and data integrity testing
- Identify, document, and troubleshoot validation deviations
- Conduct root cause analysis and collaborate with cross-functional teams to resolve issues
Risk & Change Management
- Conduct risk assessments (e.g., FMEA) to identify and mitigate system risks
- Support and implement change control procedures for software updates and enhancements
- Transition legacy SOPs to updated IT software management SOPs
Required Qualifications
- Education: Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field
- Experience: 2–5 years of experience in Computer System Validation (CSV) or software validation in regulated industries (pharmaceutical, biotech, or medical devices)
Required Skills & Competencies
Regulatory Knowledge
- 5 years of strong understanding of:
- FDA, EMA, and GMP regulations
- 21 CFR Part 11
- GAMP 5 guidelines
- Data integrity principles
Technical Expertise
- 3 to 5 years of experience with:
- Laboratory systems such as LIMS
- Chromatography Data Systems (e.g., Empower)
- Familiarity with validation lifecycle and documentation standards
Core Competencies
- Strong analytical and problem-solving skills
- Excellent technical writing and documentation abilities
- Attention to detail with a quality-focused mindset
- Ability to work cross-functionally with IT, QA, and business teams
Preferred Qualifications
- Experience in global regulatory environments
- Exposure to instrument software in laboratory or manufacturing settings
- Knowledge of SOP migration and system lifecycle management